Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

901 results for "Abbott Laboratories"
73–96 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 17, 2006
FOX SV PTA CATHETER
K062843 · LIT
Abbott Laboratories
Cardiovascular · 25d
Cleared Jul 10, 2006
CELL-DYN RUBY SYSTEM
K061667 · GKZ
Abbott Laboratories
Hematology · 26d
Cleared Jun 23, 2006
CREATININE
K061193 · CGX
Abbott Laboratories, Inc.
Chemistry · 56d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Abbott Laboratories
Chemistry · 76d
Cleared Jun 02, 2006
AXSYM DIGOXIN III
K061249 · KXT
Abbott Laboratories
Toxicology · 29d
Cleared May 05, 2006
GLUCOSE
K060383 · CFR
Abbott Laboratories
Chemistry · 80d
Cleared May 04, 2006
CARBON DIOXIDE
K060295 · KHS
Abbott Laboratories
Chemistry · 87d
Cleared May 03, 2006
TOTAL BILIRUBIN
K060574 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330 · JIT
Abbott Laboratories
Chemistry · 15d
Cleared Aug 25, 2005
ULTRA HDL
K051962 · LBS
Abbott Laboratories
Chemistry · 37d
Cleared Aug 03, 2005
ABBOTT AXSYM B12
K051327 · CDD
Abbott Laboratories
Chemistry · 75d
Cleared Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
K051215 · GKZ
Abbott Laboratories
Hematology · 70d
Cleared Jun 21, 2005
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
K051519 · LIT
Abbott Laboratories (Perclose, Inc.)
Cardiovascular · 13d
Cleared Jun 08, 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · FZP
Abbott Laboratories
General & Plastic Surgery · 36d
Cleared May 27, 2005
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
K051213 · NBW
Abbott Laboratories, Inc.
Chemistry · 15d
Cleared May 20, 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050534 · FGE
Abbott Laboratories
Gastroenterology & Urology · 79d
Cleared Feb 16, 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · FGE
Abbott Laboratories
Gastroenterology & Urology · 29d
Cleared Oct 01, 2004
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587,...
K041962 · FGE
Abbott Laboratories
Gastroenterology & Urology · 72d
Cleared Sep 10, 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · MMI
Abbott Laboratories
Chemistry · 66d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL...
K041687 · JJX
Abbott Laboratories
Chemistry · 57d
Cleared Jun 30, 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared May 11, 2004
FOX PLUS PTA CATHETER
K040954 · LIT
Abbott Laboratories, Inc.
Cardiovascular · 28d
Cleared Apr 30, 2004
AXSYM CYCLOSPORINE
K040761 · MKW
Abbott Laboratories, Inc.
Chemistry · 36d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · NBW
Abbott Laboratories
Chemistry · 16d